- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00703495
Invasive and Non-Invasive Assessment of Cerebral Oxygenation in Patients With Severe Traumatic Brain Injury (TBI)
April 3, 2009 updated by: Hospitales Universitarios Virgen del Rocío
Validation of Non- Invasive Regional Transcranial Oxygen Saturation (rSO2) by Comparison With Invasive Brain Tissue Oxygenation (PbtO 2) Measurement in Patients With Severe Traumatic Brain Injury
The purpose of this study is to investigate the relationship among regional transcranial oxygen saturation (rSO2), brain tissue oxygen pressure (PbtO2) and cerebral perfusion pressure (CPP) in patients with severe traumatic brain injury (TBI).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Experience with rsO2 assessed by near infrared spectroscopy (NIRS) in patients with severe TBI is lacking.
Reports about the usefulness of rSO2 are contradictory as regards its technical reliability and clinical value.
Continuous time-domain analysis comparing rSO2, PbtO2 and CPP has never been carried out and the correlation among these variables remains largely unknown.
A significant association between rSO2 and these clinically important variables would suggest that cerebral oximetry provides relevant data signifying that rSO2 might be a useful tool assessing cerebral oxygenation in selected patients with TBI.
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seville, Spain, 41013
- Hospital Universitario "Virgen del Rocío"
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Stable patients with severe traumatic brain injury (Glasgow Coma Scale < 9) monitored through intracranial pressure (ICP) and brain tissue partial pressure of oxygen (PbtO2) probe, inserted for indications other than inclusion in this study
Description
Inclusion Criteria:
- Severe Traumatic Brain Injury (Glasgow Coma Scale < 9)
- Having an intraparenchymal cerebral ICP/PbtO2 catheter previously inserted.
- Expected length of ICU stay > 1 days
Exclusion Criteria:
- Patient's relatives refusal to patient's inclusion in the study
- Patients necessitating ongoing resuscitation
- End-stage in which death is imminent
- Deficient signal of rSO2 impeding its proper valuation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation between rSO2 and PbtO2
Time Frame: four months
|
four months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation between rSO2 and CPP
Time Frame: four months
|
four months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Santiago R Leal-Noval, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
- Study Chair: Aurelio Cayuela, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
- Study Chair: Victoria Arellano, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
- Study Chair: Yael Corcia, M.D., Hospital Universitario "Virgen del Rocío", Seville, Spain
- Study Chair: Vicente Padilla, M.D., Hospital Universitario "Virgen del Rocío", Seville, Spain
- Study Chair: Claudio Garcia-Alfaro, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
- Study Chair: Antonio Marín, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
- Study Director: Francisco Murillo, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
- Study Chair: Rosario Amaya, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
- Study Chair: Maria Dolores Rincón, M.D., PhD, Hospital Universitario "Virgen del Rocío", Seville, Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
June 19, 2008
First Submitted That Met QC Criteria
June 20, 2008
First Posted (Estimate)
June 23, 2008
Study Record Updates
Last Update Posted (Estimate)
April 6, 2009
Last Update Submitted That Met QC Criteria
April 3, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI 06/2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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